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510(k) K801388

OH-HARRIS by Johnson & Johnson Professionals, Inc. — Product Code KIH

K801388 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "OH-HARRIS". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code KIH (Dispenser, Cement), a Class I device regulated under 21 CFR 888.4200. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
June 13, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Cement
Device Class
Class I
Regulation Number
888.4200
Review Panel
OR
Submission Type

Other clearances by Johnson & Johnson Professionals, Inc.

  • K992173 — SIPHONGUARD CSF CONTROL DEVICE (April 7, 2000)
  • K991413 — CODMAN ETHISORB DURA PATCH (March 13, 2000)
  • K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT (July 9, 1999)
  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) (December 4, 1998)
  • K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (November 6, 1998)
  • K983014 — SUMMIT ACETABULAR SYSTEM (October 27, 1998)
  • K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (July 17, 1998)
  • K974739 — HAKIM PROGRAMMABLE VALVE SYSTEM (July 1, 1998)
  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

Other clearances for product code KIH

  • K042591 — SMARTMIX PRE-FILLED MIXING SYSTEM (October 22, 2004)
  • K943906 — P.F.C. CEMENT PRESSURIZING SYSTEM (December 21, 1994)
  • K897134 — CMW CEMENT PRESSURISATION SYSTEM (March 2, 1990)
  • K851881 — ORTHOPEADIC CEMENT DELIVERY SYSTEM (June 13, 1985)
  • K840046 — PRESSURIZING/SCAVENGING ACRYLIC CEMENT (February 9, 1984)
  • K833675 — BRIGHAM TIBIAL CEMENT PRESSURIZER (December 12, 1983)
  • K811317 — HOWMEDICA FEMORAL PRESSURING SEAL (May 29, 1981)
  • K790275 — GUN, EXETER CEMENT (February 21, 1979)
  • K781955 — GUN, CEMENT (December 4, 1978)
  • K780266 — BONE CEMENT APPLICATOR (February 28, 1978)

FDA data resources